BriaCell Adds Key Clinical Sites in Phase 3 Metastatic Breast Cancer Study
BriaCell (Nasdaq: BCTX) added Dartmouth Cancer Center, Cedars-Sinai Medical Center, and Winship Cancer Institute of Emory University to its pivotal Phase 3 metastatic breast cancer study (ClinicalTrials.gov NCT06072612).
The trial now has 79 clinical sites across 23 US states enrolling patients and evaluates Bria-IMT plus an immune checkpoint inhibitor versus physician’s choice. Interim analysis is planned once 144 patient events (deaths) occur, and the company anticipates reporting top-line data as early as H1-2026. The Bria-IMT regimen holds FDA Fast Track designation.
BriaCell (Nasdaq: BCTX) ha aggiunto Dartmouth Cancer Center, Cedars-Sinai Medical Center e Winship Cancer Institute of Emory University al suo studio pivotale di fase 3 sul cancro metastatico al seno (ClinicalTrials.gov NCT06072612).
Lo studio ora comprende 79 siti clinici in 23 stati degli Stati Uniti e valuta Bria-IMT più un inibitore del checkpoint immunitario rispetto alla scelta del medico. L'analisi intermedia è prevista non appena si verificheranno 144 eventi di pazienti (decessi), e la società prevede di riportare i dati principali già nel primo semestre del 2026. Il regime Bria-IMT ha designation Fast Track della FDA.
BriaCell (Nasdaq: BCTX) agregó Dartmouth Cancer Center, Cedars-Sinai Medical Center y Winship Cancer Institute of Emory University a su estudio pivotal de Fase 3 sobre cáncer de mama metastásico (ClinicalTrials.gov NCT06072612).
El ensayo ahora cuenta con 79 sitios clínicos en 23 estados de EE. UU. realizando reclutamiento y evalúa Bria-IMT más un inhibidor de punto de control inmunitario frente a la elección del médico. Se planea un análisis interino una vez que ocurran 144 eventos en pacientes (fallecimientos), y la empresa espera presentar los datos principales tan pronto como el primer semestre de 2026. El régimen Bria-IMT tiene designación Fast Track de la FDA.
BriaCell (나스닥: BCTX)은 중요한 위약 3상 다발성 유방암 연구에 Dartmouth Cancer Center, Cedars-Sinai Medical Center 및 Winship Cancer Institute of Emory University를 추가했습니다 (ClinicalTrials.gov NCT06072612).
이 연구는 이제 미국 23개 주의 79개 임상 사이트를 포함하고 있으며 면역 체크포인트 억제제와 Bria-IMT를 결합한 요법을 의사의 선택과 비교 평가합니다. 중간 분석은 144건의 환자 이벤트(사망)가 발생하면 계획되어 있으며, 회사는 상위 결과를 최소 2026년 상반기까지로 보고할 것으로 예상합니다. Bria-IMT 요법은 FDA Fast Track 지정을 받았습니다.
BriaCell (NASDAQ : BCTX) a ajouté le Dartmouth Cancer Center, le Cedars-Sinai Medical Center et le Winship Cancer Institute de l'Université Emory à son étude pivôtale de phase 3 sur le cancer du sein métastatique (ClinicalTrials.gov NCT06072612).
L'essai compte désormais 79 sites cliniques dans 23 états américains recrutant des patients et évalue Bria-IMT plus un inhibiteur de point de contrôle immunitaire comparé au choix du médecin. Une analyse intermédiaire est prévue une fois 144 événements chez les patients (décès) survenus, et la société prévoit de communiquer les données principales dès le premier semestre 2026. Le régime Bria-IMT bénéficie d'une désignation FDA Fast Track.
BriaCell (NASDAQ: BCTX) hat Dartmouth Cancer Center, Cedars-Sinai Medical Center und Winship Cancer Institute der Emory University zu seiner prädestinierten Phase-3-Studie zum metastatischen Brustkrebs hinzugefügt (ClinicalTrials.gov NCT06072612).
Die Studie hat nun 79 klinische Zentren in 23 US-Bundesstaaten, in denen Patienten eingeschrieben werden, und bewertet Bria-IMT plus einen Immun-Checkpoint-Inhibitor im Vergleich zur Wahl des Arztes. Eine Zwischenanalyse ist geplant, sobald 144 Patientenevents (Todesfälle) auftreten, und das Unternehmen rechnet damit, die Topline-Daten so früh wie im 1. Halbjahr 2026 zu berichten. Das Bria-IMT-Regime verfügt über die FDA Fast Track–Zuerkennung.
BriaCell (بورصة ناسداك: BCTX) أضافت Dartmouth Cancer Center، Cedars-Sinai Medical Center، وWinship Cancer Institute من جامعة إيموري إلى دراستها المحورية من المرحلة الثالثة لسرطان الثدي النقلي (ClinicalTrials.gov NCT06072612).
التجربة لديها الآن 79 مركزًا سريريًا عبر 23 ولاية أمريكية تجري تسجيل المرضى وتقيّم Bria-IMT بالإضافة إلى مثبِّط نقطة تفتيش مناعي مقابل اختيار الطبيب. من المخطط إجراء تحليل وسيط بمجرد حدوث 144 حدثًا لدى المرضى (وفيات)، وتتوقع الشركة الإبلاغ عن البيانات الرئيسية في أقرب فترة النصف الأول من عام 2026. نظام Bria-IMT لديه تعيين FDA Fast Track.
BriaCell (纳斯达克：BCTX) 将达特茅斯癌症中心、 Cedars-Sinai 医疗中心以及艾默里大学 Winship 癌症研究所加入其关键的第三阶段转移性乳腺癌研究（ClinicalTrials.gov NCT06072612）。
该试验现已拥有 在23个美国州的79个临床点，并评估 Bria-IMT 加免疫检查点抑制剂 相较于医生的选择。计划在发生 144 例患者事件（死亡） 时进行中期分析，公司预计在 2026 年上半年披露初步结果。Bria-IMT 方案具有 FDA Fast Track 指定。
- 79 clinical sites enrolling across 23 US states
- New top centers: Dartmouth, Cedars-Sinai, Emory Winship
- Top-line data anticipated as early as H1-2026
- FDA Fast Track designation for Bria-IMT regimen
- Interim analysis contingent on 144 patient deaths
- No clinical efficacy results reported yet from the Phase 3 study
Insights
Phase 3 enrollment accelerates with major centers added; interim analysis expected after 144 events and topline in
BriaCell expands its pivotal trial to 79 sites across 23 states and added large academic centers including Dartmouth Cancer Center, Cedars-Sinai Medical Center, and Winship Cancer Institute of Emory University. Broader site coverage usually shortens enrollment timelines and improves access to diverse patient pools, which matters when interim analysis depends on event accrual.
Key dependencies include actual enrollment rates at the new sites and speed of event accumulation until 144 patient deaths trigger the interim OS analysis. Monitor recruitment cadence, site activation dates, and data-readiness milestones between now and
Adding top cancer centers strengthens trial credibility and may increase chance to meet the interim OS milestone needed for regulatory progress.
The trial evaluates Bria-IMT plus a checkpoint inhibitor versus physician’s choice with overall survival as the primary endpoint and an interim analysis after 144 events. The regimen already holds FDA Fast Track designation, which can speed regulatory interactions if results are positive.
Risks remain tied to the unknown outcome of the OS analysis and timing of event accrual; watch the reported enrollment rate, site activation confirmations, and the timing when 144 events are reached, particularly before the projected
- 79 clinical sites across 23 US states are currently enrolling patients in BriaCell’s pivotal Phase 3 study in metastatic breast cancer (MBC)
- Dartmouth Cancer Center, Cedars-Sinai Medical Center, and Winship Cancer Institute of Emory University have now joined BriaCell’s extensive national network
PHILADELPHIA and VANCOUVER, British Columbia, Oct. 21, 2025 (GLOBE NEWSWIRE) -- BriaCell Therapeutics Corp. (Nasdaq: BCTX, BCTXW) (TSX: BCT) (“BriaCell” or the “Company”), a clinical-stage biotechnology company that develops novel immunotherapies to transform cancer care, is pleased to announce the addition of several key large cancer centers to its ongoing pivotal Phase 3 clinical study (ClinicalTrials.gov as NCT06072612), notably Dartmouth Cancer Center, Cedars-Sinai Medical Center, and Winship Cancer Institute of Emory University. BriaCell anticipates reporting top line data as early as H1-2026.
The extensive national effort already includes the following noteworthy clinics: Mayo Clinic, Los Angeles Cancer Network, Smilow Cancer Hospital at Yale New Haven, Sylvester Comprehensive Cancer Center, Cancer Care Northwest, Hematology Oncology Associates of Fredericksburg, Northwestern University, Manhattan Hematology/Oncology Associates, New York Cancer and Bood Specialists, and Texas Oncology-Baylor Charles A. Sammons Cancer Center.
BriaCell’s pivotal Phase 3 clinical study is evaluating BriaCell’s lead clinical candidate, Bria-IMT, plus immune check point inhibitor versus physician’s choice of treatment in advanced metastatic breast cancer (Bria-ABC).
“We are encouraged by the strong engagement from major academic and leading community cancer centers which underscores confidence in BriaCell’s novel technology,” stated Dr. William V. Williams, BriaCell’s President & CEO. “We expect the addition of these clinical sites will further accelerate patient enrollment in BriaCell’s pivotal Phase 3 study of Bria-IMT regimen in MBC and support our mission to bring this therapy to patients with significant unmet medical needs.”
About BriaCell’s Pivotal Phase 3 Clinical Study of Bria-IMT Combination Regimen in MBC patients
BriaCell’s pivotal Phase 3 study of Bria-IMT plus an immune check point inhibitor (CPI) in metastatic breast cancer is ongoing.
Interim data will be analyzed once 144 patient events (deaths) occur, comparing the overall survival (OS) in patients treated with the Bria-IMT combination regimen versus those treated with physician’s choice as the primary endpoint. Positive results of the pivotal Phase 3 study could result in full approval and marketing authorization for Bria-IMT in MBC patients. The Bria-IMT combination regimen has received FDA Fast Track designation.
For additional information on BriaCell’s pivotal Phase 3 study of Bria-IMT and an immune check point inhibitor in metastatic breast cancer, please visit ClinicalTrials.gov NCT06072612.
About BriaCell Therapeutics Corp.
BriaCell is a clinical-stage biotechnology company that develops novel immunotherapies to transform cancer care. More information is available at https://briacell.com/.
Safe Harbor
This press release contains “forward-looking statements” that are subject to substantial risks and uncertainties. All statements, other than statements of historical fact, contained in this press release are forward-looking statements. Forward-looking statements contained in this press release may be identified by the use of words such as “anticipate,” “believe,” “contemplate,” “could,” “estimate,” “expect,” “intend,” “seek,” “may,” “might,” “plan,” “potential,” “predict,” “project,” “target,” “aim,” “should,” “will,” “would,” or the negative of these words or other similar expressions, although not all forward-looking statements contain these words. Forward-looking statements, including those about: the Company’s anticipated expansion of patient enrollment; the Company's anticipated timeline for analyzing and reporting interim and top line data in its ongoing pivotal Phase 3 clinical study; and the Company’s beliefs regarding its ability to bring their novel immunotherapy to patients with unmet medical needs; are based on BriaCell’s current expectations and are subject to inherent uncertainties, risks, and assumptions that are difficult to predict. Further, certain forward-looking statements, such as those are based on assumptions as to future events that may not prove to be accurate. These and other risks and uncertainties are described more fully under the heading “Risks and Uncertainties” in the Company’s most recent Management’s Discussion and Analysis, under the heading “Risk Factors” in the Company’s most recent Annual Information Form, and under “Risks and Uncertainties” in the Company’s other filings with the Canadian securities regulatory authorities and the U.S. Securities and Exchange Commission, all of which are available under the Company's profiles on SEDAR+ at www.sedarplus.ca and on EDGAR at www.sec.gov. Forward-looking statements contained in this announcement are made as of this date, and BriaCell Therapeutics Corp. undertakes no duty to update such information except as required under applicable law.
Neither the Toronto Stock Exchange nor its Regulation Services Provider (as that term is defined in the policies of the Toronto Stock Exchange) accepts responsibility for the adequacy or accuracy of this release.
Contact Information
Company Contact:
William V. Williams, MD
President & CEO
1-888-485-6340
info@briacell.com
Investor Relations Contact:
investors@briacell.com
FAQ
Which new clinical sites joined BriaCell's Phase 3 MBC trial for BCTX on October 21, 2025?
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